Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05349292

Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels

Acute normovolemic hemodilution (ANH) is performed as a blood conservation technique during surgical procedures with high risk for significant blood loss. It is done by taking out some of the patients blood before surgery actually begins and storing this blood inside of the operating room and giving it back to the patient at the end of surgery when most of the expected surgical bleeding has already occurred. This practice reduces the amount of bleeding that occurs after surgery and also reduces the amount of blood transfusions given to the patient after surgery. Transfusion of blood products from the blood bank may cause problems such as transfusion reactions and infections like hepatitis, and also increases cost.

3 meta-analyses and several smaller trials have shown improvement in blood transfusion rates with the use of ANH, however there is no evidence of improvement in other complication rates, morbidity and mortality, length of stay or cost.

In most types of surgery, when ANH is done, large volumes of IV fluids are given to the patient to prevent a drop in circulatory volume and blood pressure. However during heart surgery, this can cause significant levels of hemodilution in addition to that caused by use of the heart-lung machine. In order to minimize hemodilution when ANH is performed during heart surgery, a smaller amount of IV fluids are given to the patient after blood is drawn. Vasoactive medications are then administered to prevent the blood pressure from dropping.

Kidney injury is a recognized complication that may occur after heart surgery. It may be caused by low blood volume, low blood pressure and anemia. It is not known whether performance of ANH and use of the heart-lung machine may increase risk for kidney injury. Kidney injury is associated with increased risk for other medical complications and death. This increased risk for kidney injury arising from ANH has not been evaluated. This study will therefore compare patients treated with ANH to those not treated with ANH to determine whether there is an increased risk for kidney injury with the use of ANH.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Patrick Odonkor, MD

CONTACT

About this study

The study population will consist of 50 adult patients less than 70 years old undergoing elective coronary artery bypass graft (CABG) surgery with anticipated CPB duration less than 2 hours at the University of Maryland Medical Center (UMMC). Patients less than 70kg in weight and patients with renal insufficiency and/or hemoglobin levels less than 12g/dL will be excluded. We shall also exclude patients with heart failure (EF <40%) and any significant hepatic or pulmonary comorbidities, including pulmonary hypertension. Patients undergoing emergency and redo cardiac surgery and those with inherited or acquired bleeding disorders will also be excluded.

This study will be a non-blinded randomized prospective observational study. Due to the nature of the intervention being evaluated, blinding will not be achievable. We shall randomly divide patients into 2 groups, where one group will be managed with ANH and the other without (control group). Patients managed with ANH will have 12cc/kg of blood salvaged and stored at room temperature prior to CPB. The stored blood will then be administered to the patient after CPB. Intravascular volume will be replenished in a 1:1 ratio with balanced crystalloid solution during blood salvage. The other group of patients will receive an empiric 7cc/kg bolus of intravenous balanced crystalloid solution prior to CPB. On average, crystalloid infusions are limited to about 500cc prior to CPB to minimize hemodilution of blood.

Patients will otherwise be managed according to normal protocols and pathways used in the perioperative management of CS patients at UMMC.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective Coronary Artery Bypass Graft Surgery
  • Age 18-70 years
  • Anticipated Cardiopulmonary Bypass Duration less than 2 hours
  • Weight greater than 70kg
  • Hemoglobin greater than 12 g/dL

Exclusion criteria

  • Emergency and redo cardiac surgery
  • Renal insufficiency with serum creatinine greater than 1.25 mg/dL and/ or estimated GFR less than 60 mL/min/1.73 m2
  • Heart Failure with EF <40%
  • Hepatic disease
  • Pulmonary Disease, including pulmonary hypertension
  • Inherited or Acquired Bleeding Disease

Treatment and study plan

ANH

Other

one group will be managed with ANH and the other without (control group)

Primary outcomes

  1. Urinary Biomarkers NGAL and KIM-1

    Time frame: 24 hours

    Urinary levels of NGAL and KIM-1 biomarkers during the first 24 hours after CABG surgery

Secondary outcomes

  1. AKI by KDIGO criteria

    Time frame: 72 hours

    Creatinine values and urine output for 3 days after CS will be recorded for calculation of AKI by KDIGO criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittney Williams, MD

CONTACT

[email protected]

4103286120

Patrick Odonkor, MD

CONTACT

[email protected]

4103286120

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Effect of Low-volume Fluid Replacement Strategy During Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels: an Acute Kidney Injury Biomarker

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.